Knee OsteoarthritisPhase 3NCT00265447
Exercise and Physical Fitness for Persons With Knee Osteoarthritis
A Phase 3 study testing Strength training, Aerobic conditioning and Delayed exercise in people with Knee Osteoarthritis, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The purpose of this project is to establish evidence to support specific, targeted exercise and rehabilitation recommendations for people over 50 with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Strength training, Aerobic conditioning and Delayed exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jul 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- community-dwelling, physician diagnosed osteoarthritis of the knee, willingness to exercise regularly, willingness to perform 3 testing sessions over a 6-month period, ability to exercise safely at a moderate level of intensity, knee osteoarthritis by clinical criteria,
- WOMAC Scores as follows:
- PAIN:"mild" pain on 2 items or "moderate" pain on 1 item; PHYSICAL FUNCTION: "mild" difficulty in 4 items or "moderate" difficulty in 2 items -
Who cannot join
- age<50,inability to exercise and ambulate independently, physical limitation secondary to a condition that is not modifiable by exercise (e.g., active cancer), knee replacement (past or scheduled), total hip joint replacement less than 6 months ago, current participation in regular conditioning exercise, participation in another research study,
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise and Physical Fitness for Persons With Knee Osteoarthritis: Does One Size Fit All
The purpose of this project is to establish evidence to support specific, targeted exercise and rehabilitation recommendations for people over 50 with osteoarthritis of the knee.
Read the detailed description
Physical disability and poor health often accompany knee osteoarthritis (OA), particularly as people age. This decline in function and quality of life is a complex phenomenon associated with numerous factors including pain, poor physical fitness, obesity, co-morbidity, low self-efficacy and lower extremity impairments. Furthermore, the effects of age, which have not been well studied in OA, must be considered. In addition to the functional losses associated with knee OA and aging, low levels of daily physical activity and exercise are common problems in this population for whom arthritis is a major reason for activity limitation. Evidence is accumulating that exercise can enhance health and quality of life and modify a number of the factors associated with disability. There is, however, little specific information to guide exercise prescription in the diverse population of people with knee OA. Although general benefit of exercise has been demonstrated, it is time to focus research questions on the specific types of exercise that produce specific effects; and for whom particular exercises are the most useful. Additionally, exercise has shown short term benefit, but how best to maintain gains and sustain exercise behaviors in self-directed and community settings is virtually untested. These questions are relevant to all people with knee OA, and become even more important as people grow older, become more sedentary and are at greater risk for frailty, poor health and disability.
This study is designed to: determine the efficacy of specific types of exercise by examining the effects of training on physiologic adaptations and physical performance; determine the effectiveness of a comprehensive exercise protocol performed in a supervised but non-medical setting, and describe the interaction of personal characteristics and disease severity with individual response to a particular exercise regimen.
- Conditions
- Knee Osteoarthritis
- Being tested
- Strength training, Aerobic conditioning, Delayed exercise
- Keywords
- knee osteoarthritis, exercise, aerobic exercise, strengthening exercise, exercise prescription, rehabilitation, physical disability, physical function, physical activity, physical fitness
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingBehavioural
3 months of strength training
Aerobic conditioningBehavioural
3 months of aerobic conditioning
Delayed exerciseBehavioural
delayed exercise control group
| Study group | Role | What they receive |
|---|---|---|
| Strength training | Active comparator | 3 months of strength training Receives: Behavioral: Strength training |
| Aerobic conditioning | Active comparator | 3 months of aerobic conditioning Receives: Behavioral: Aerobic conditioning |
| Delayed exercise | Other | delayed exercise control group Receives: Behavioral: Delayed exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC Pain scale
Measured: baseline, 3 months, and 6 months
WOMAC physical function scale, muscle performance,flexibility, aerobic capacity, self-reported health status
Measured: baseline, 3 months, 6 months
Secondary outcomes (1)
AIMS2
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Sponsor
- Investigators
- Marian A Minor, PhD, Principal investigator, Department of Physical Therapy, School of Health Professions, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265447
- Sponsor's protocol ID
- H133B031120-Proj 2
- Status last verified
- Sep 2016
- First submitted
- 13 Dec 2005
- Last updated
- 28 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Physical Fitness for Persons With Knee Osteoarthritis: Does One Size Fit All
- ClinicalTrials.gov ID
- NCT00265447
- Acronym / sponsor ID
- H133B031120-Proj 2
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, exercise, aerobic exercise, strengthening exercise, exercise prescription, rehabilitation, physical disability, physical function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Dec 2005
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 14 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to establish evidence to support specific, targeted exercise and rehabilitation recommendations for people over 50 with osteoarthritis of the knee.
Detailed description
Physical disability and poor health often accompany knee osteoarthritis (OA), particularly as people age. This decline in function and quality of life is a complex phenomenon associated with numerous factors including pain, poor physical fitness, obesity, co-morbidity, low self-efficacy and lower extremity impairments. Furthermore, the effects of age, which have not been well studied in OA, must be considered. In addition to the functional losses associated with knee OA and aging, low levels of daily physical activity and exercise are common problems in this population for whom arthritis is a major reason for activity limitation. Evidence is accumulating that exercise can enhance health and quality of life and modify a number of the factors associated with disability. There is, however, little specific information to guide exercise prescription in the diverse population of people with knee OA. Although general benefit of exercise has been demonstrated, it is time to focus research questions on the specific types of exercise that produce specific effects; and for whom particular exercises are the most useful. Additionally, exercise has shown short term benefit, but how best to maintain gains and sustain exercise behaviors in self-directed and community settings is virtually untested. These questions are relevant to all people with knee OA, and become even more important as people grow older, become more sedentary and are at greater risk for frailty, poor health and disability.
This study is designed to: determine the efficacy of specific types of exercise by examining the effects of training on physiologic adaptations and physical performance; determine the effectiveness of a comprehensive exercise protocol performed in a supervised but non-medical setting, and describe the interaction of personal characteristics and disease severity with individual response to a particular exercise regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strength training | Active comparator | Behavioral: Strength training3 months of strength training |
| Aerobic conditioning | Active comparator | Behavioral: Aerobic conditioning3 months of aerobic conditioning |
| Delayed exercise | Other | Behavioral: Delayed exercisedelayed exercise control group |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- community-dwelling, physician diagnosed osteoarthritis of the knee, willingness to exercise regularly, willingness to perform 3 testing sessions over a 6-month period, ability to exercise safely at a moderate level of intensity, knee osteoarthritis by clinical criteria,
- PAIN:"mild" pain on 2 items or "moderate" pain on 1 item; PHYSICAL FUNCTION: "mild" difficulty in 4 items or "moderate" difficulty in 2 items -
Key exclusion criteria (2 listed)
- age<50,inability to exercise and ambulate independently, physical limitation secondary to a condition that is not modifiable by exercise (e.g., active cancer), knee replacement (past or scheduled), total hip joint replacement less than 6 months ago, current participation in regular conditioning exercise, participation in another research study,
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength training3 months of strength training | Behavioural | Strength training |
| Aerobic conditioning3 months of aerobic conditioning | Behavioural | Aerobic conditioning |
| Delayed exercisedelayed exercise control group | Behavioural | Delayed exercise |
Primary outcome
WOMAC Pain scale
Time frame: baseline, 3 months, and 6 months
WOMAC physical function scale, muscle performance,flexibility, aerobic capacity, self-reported health status
Time frame: baseline, 3 months, 6 months
1 secondary outcome
AIMS2
Time frame: baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marian A Minor, PhD principal investigator
Department of Physical Therapy, School of Health Professions, University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Strength training, Aerobic conditioning and Delayed exercise in people with Knee Osteoarthritis, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC Pain scale (time frame: baseline, 3 months, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.